Analytical Industrialization Leader

☞ GSK

전망: 155

갱신일: 16-11-2025

위치: Wavre Walloon Brabant

범주: R & D 과학 IT-소프트웨어

산업: Pharmaceuticals

직업 종류: Full-time

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작업 내용

Site Name: Belgium-Wavre
Posted Date: Apr 29 2021

Job purpose: As Analytical Industrialization Leader (AIL) of the Physico-Chemistry platform of Analytical R&D (ARD, Belgium), your goal is to ensure GMP-compliance and QC-friendliness of the analytical methods developed in the platform and transferred to QC. You will interact closely with the technological teams to embed Quality by Design (QbD) principles and phase-appropriate approach in method development. You will also act as a team with other AILs to strive for harmonization between the ARD platforms.

Your Responsibilities
  • You actively participate as advisor to QbD exercises such as Analytical Target Profile, Method Screening and Method Development (including DoE), together with platforms and Analytical Product Leader (APL).
  • You are involved in the design of method qualification and validation, and you ensure qualification and validation documents review and sign-off (protocol, report).
  • You support and facilitate transfer to QC, as well as transfer from SOE to GMP environments within ARD (e.g. US to BE). You collaborate with APL to TTP/TTR strategy.
  • You collaborate closely with platforms with respect to implementation of new technologies and check for long-term adoption in QC. You support design of GMP Equipment park.
  • You seek harmonization/alignment between Drug Substance, Drug Product and ARD from the analytical standpoint (e.g. in-process tests, use of new technologies).
  • You are involved in the elaboration of reference standard strategy (identification, control strategy, bridging).
  • Together with the other AILs, you lead the meeting for validation and statistical alignment, you share the accountability for the management of analytical validation master plan (AVMP), and you are a Business SPOC for Analytical Validation Network. You approve the qualification status document on behalf of QC, for methods performed in commercial QC.
  • You support harmonization of the GMP processes and SOP requirements for assays between Rosia, Italy and Belgium-QC.
  • You support readiness to L3/L4 Audits.
Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:
  • Masters, PhD, or equivalent practical work experience in relevant discipline (consult manager on equivalent practical work experience in relevant discipline).
  • Knowledge of GMP requirements and guidelines.
Broader expertise on most of technologies in place in the platform and currently transferable to QC: SEC-HPLC, DLS, Colorimetric assays, NMR.
  • Internal and external network.
  • Organization skills.
  • Agility and flexibility; polyvalence.
  • Ready to play a central role in ARD organization.
  • English fluency (written/oral); good French understanding is necessary (daily interactions with floor scientists in Belgian-based platform).
Preferred Qualifications

If you have the following characteristics it would be a plus:
  • Communication and leadership skills.
  • Good knowledge of technologies currently used for characterization: FTIR, Fluorescence, Circular dichroism, Mass Spectrometry, MALLS, Electron microscopy.
Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
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마감 시간: 31-12-2025

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